Obese patients lost a substantial amount of weight after transcatheter bariatric embolotherapy (TBE) of the left gastric artery (LGA), a randomized trial showed.
Total body weight loss reached 7.4 kg (16.3 lbs) 6 months after TBE in 19 patients, a significant improvement over the 3.0 kg (6.6 lbs) lost by 18 control patients after a sham procedure. Results were similar on per-protocol analysis, excluding those with unsuccessful embolization and comorbidities meeting exclusion criteria, according to the LOSEIT (Lowering Weight in Severe Obesity by Embolization of the Gastric Artery Trial) group led by Vivek Reddy, MD, of the Icahn School of Medicine at Mount Sinai in New York City.
Total body weight loss was maintained out to 12 months among TBE recipients.
A full report of the trial appeared in the November 17 issue of the Journal of the American College of Cardiology, with the main findings previously reported during this year’s virtual PCR e-Course.
TBE, or bariatric arterial embolization (BAE), involves occlusion balloon microcatheter-directed embolization of the LGA using small embolic beads in a saline solution. This closes off blood supply to the gastric fundus, thereby blocking the majority of cells that produce the appetite-stimulating hormone ghrelin.
Reddy and colleagues reported that ghrelin reductions were similar between groups at 6 months (median -12.2% in the TBE group vs -3.4% in controls, P=0.45), but the TBE arm did have a significant median 15.5% decrease in the hunger hormone from baseline to 12 months (P=0.035).
All 19 TBE procedures had been performed at Homolka Hospital in Prague.
There were zero device-related complications and one vascular complication. Adverse events after TBE included mild nausea and vomiting and some epigastric pain treated with paracetamol. Endoscopy within 1 week post-procedure revealed minor self-limiting ulcers in five patients.
“Although a panacea for obesity is unlikely, these data indicate that, if confirmed to be safe and effective in larger future trials, embolotherapy might play an important role in mitigating this global health epidemic,” Reddy and colleagues concluded.
Bariatric surgery likely continues to be the most effective weight loss treatment, with TBE on par with many medications, according to Clifford Weiss, MD, and Christopher Bailey, MD, both of Johns Hopkins Hospital in Baltimore, writing in an accompanying editorial.
“However, BAE is not meant to replace bariatric surgery, diet, exercise, and weight-loss medications. Instead, BAE will probably fall somewhere in between lifestyle management and surgery, and hopefully will be part of a multidisciplinary approach to treating patients with obesity,” Weiss and Bailey said.
Moreover, TBE shows promise for a wide swath of patients, Reddy and colleagues suggested. “If TBE’s efficacy and safety are confirmed in large multicenter trials, it might be employed not only in the general population with obesity, but also in patients with cardiovascular or metabolic comorbidities who seldom visit specialized weight loss clinics.”
“A 5-10% weight loss, an effect achievable with TBE, has been associated with clinically meaningful reductions in hemoglobin A1c, triglycerides, low-density lipoprotein cholesterol, and systolic blood pressure,” the researchers noted. “Although our study was not powered to directly assess changes in these outcomes, there was evidence for an almost 10-mm Hg decrease in mean diastolic blood pressure in the treatment group.”
LOSEIT included 44 obese people — body mass index (BMI) of 35.0-55.0 — who were randomized 1:1 to sham or TBE. Sham procedures consisted of sedation and subcutaneous lidocaine injection without arterial access. All patients also entered a 19-session lifestyle counseling program.
The average age of the participants was 45.5 years, and more than 80% of the cohort were women. Mean BMI was 39.6, and weight was 114.5 kg (252.4 lbs). Baseline characteristics were similar between groups, the researchers reported.
Prior attempts at weight loss were most commonly diet alone (70.5% of participants) and diet plus medications (20.5%).
Twenty people remained in each group after four withdrew consent prior to any treatment. Two TBE recipients underwent bariatric surgery about 1.5 years after the procedure.
“Importantly, preliminary evidence from both the current study and from a handful of case reports suggests that BAE may not preclude future bariatric surgery,” Weiss and Bailey noted.
The LOSEIT team acknowledged that patients had been unblinded after 6 months, and that the results of the trial will need to be confirmed in larger studies.
Planned follow-up of the present cohort has been extended to 3 years, Reddy and co-authors said.
Weiss and Bailey speculated that repeat embolization may be needed to sustain or improve weight loss after TBE, and whether the embolic beads used in the study are ideal for TBE is also unknown, they said.
“Although questions remain, BAE remains an exciting, innovative, minimally invasive procedure with the potential to play a significant role in the treatment of the patient with obesity,” the editorialists stated.
Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow
The study was funded by Endobar Solutions.
Reddy reported financial relationships or having equity with Abbott, Abiomed, Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atavor Autonomix, Axon, BackBeat, BioSig, Biosense-Webster, Biotronik, Boston Scientific, CardioFocus, Cardionomic, CardioNXT/AFTx, Circa Scientific, Corvia Medical, Dinova, East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Firel, Impulse Dynamics, InterShunt, Javelin, LuxMed, Manual Surgical Sciences, MedLumics, Medtronic, Newpace, Nuvera, Philips, Pulse Biosciences, Sirona, sureCore, Valcare, and Vizaremed.
Weiss reported financial relationships with Boston Scientific/BTG, Medtronic, and Siemens Healthcare; Bailey had no disclosures.